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Completed

NCT Number: NCT02567201

Electrophysiological Evaluation of Voluntary Attention

Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention

Material and Methods:

Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile)

Sudy 1: passive recording.

Study 2: active recording (instruction of attentional control given to the subject).

Study 3: active recording with a feedback obtained after a processing of the brain activity.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Médical de L'argentière, Aveize, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for patients :

  • Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
  • Diagnosis :
  • Locked-in syndrome :

< Brainstem injury, without any evolution for at least 3 week, etiology : vascular, traumatic < Amyotrophic Lateral Sclerosis < Following damage to the central or peripheral nervous system

  • Or Minimal conscious state or Unresponsive Wakefulness Syndrome consecutive to a severe acquired brain injury for at least one month
  • Or with a severe brain injury, since birth or acquired, for at least one month
  • Or with Guillain-Barré syndrome
  • Subjects affiliated to social security;
  • Signature of consent form by the patient or by a relative (family member or "the trusted person") if obtaining a consent is impossible

Inclusion criteria

of Healthy subjects

  • Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
  • Without known auditory impairment
  • Subjects able to understand the experimental instructions
  • Subjects affiliated to social security;
  • Signature of consent form

Exclusion criteria

of patients and healthy subjects

  • Medical history : psychiatric disorders (except if due to brain injury), neurologic disorders (except if due to brain injury)
  • For healthy subjects : history of brain injury
  • Pregnant women or breastfeeding women
  • Person under legal protection
  • Medico-legal conflicts
  • Absence of consent by the subject or the patient or his/her representant

Treatment and study plan

electrophysiological evaluation

Other

electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1, 2, 3 : one session maximum by experience

electrophysiological evaluation of patients

Other

electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1 : maximum one session by sensory modality of stimulation (auditory, tactile, or visual) Experience 2 : maximum one session by sensory modality of stimulation (auditory, tactile, or visual) Experience 3 : Stimulation = auditory or visual ; possibility of several sessions if the patient is tired.

Primary outcomes

  1. Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition

    Time frame: through study completion, an average of 3 years

    stastical analysis allowing to compare evoked responses during different stimulation condition (attentionnaly oriented versus attentionnally distracted versus passive condition = no instruction to the subject). These comparisons are made either for one single subject and at the group level. Analysis mainly concerns the differences in amplitude variation between the differents evoked potentials on several electrods of interest. These can vary between patients because of the different topographies of lesions and because of the different adaptative strategies. The statiscal difference will be assessed by a randomization test (also called "permutation test") wich allow to assess how high is the risk that the observed difference between the evoked potential (amplitude, variance) is due to chance or not

Secondary outcomes

  1. Online and offline accuracy

    Time frame: through study completion, an average of 3 years.

    percentage of correct answers with the brain-computer interface (BCI). A "correct answer" is recorded each time the feedback of the BCI match the command sended by the subject controlling the BCI. This analysis can be done online and offline. Online accuracy is recorded in real-time during the session with the subject. offline accuracy is obtained a posteriori of the experiment, to test the impact on accuracy of the changes in different parameters (stimuli duration, numbers of spatial filtering, change of classifiers, etc.).

  2. Clinical scale score ("Evaluation de la Communication des patients en Eveil de Coma" (ECEC) scale)

    Time frame: an average of 3 years (At the group level)

    this clinical scale allow to obtain an outcome measure of the investissment, the communication themes and the communication modes of the patient. The final global value range between 0 and 44.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: EVA

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2015
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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